BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17209305 · Received June 27, 2023

    Report

    Report Number
    2955842-2023-16642
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 29, 2023
    Report Date
    May 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CADIERE FORCEPS WAS ANALYZED AND THE COMPLAINT REGARDING CADIERE FORCEPS WAS NOT CONFIRMED BY FAILURE ANALYSIS. FAILURE ANALYSIS (FA) INVESTIGATIONS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION WAS CONDUCTED BY FA WHICH DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE CADIERE FORCEPS INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE CADIERE FORCEPS INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE CADIERE FORCEPS INSTRUMENT GRASPED AND RELEASED WITHOUT ANY ISSUES ON MULTIPLE ATTEMPTS. THE CADIERE FORCEPS INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CADIERE FORCEPS INSTRUMENT FOR EVALUATION, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO REMOVE THE CADIERE FORCEPS INSTRUMENT FROM THE UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) DUE TO THE INSTRUMENT TIP BECOMING STUCK AT THE CANNULA. THE SYSTEM PROMPT FOR "ARM NOT READY" WAS DISPLAYED AT THE TIME OF THE ISSUE. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SERVICE ENGINEER (TSE). THE CUSTOMER WAS ADVISED TO EITHER MANUALLY REMOVE THE CADIERE FORCEPS INSTRUMENT USING ADDITIONAL FORCE OR TO REMOVE THE INSTRUMENT WITH THE CANNULA SIMULTANEOUSLY. THE USER OBSERVED A PLASTIC COMING OUT OF THE JOINT WHEN THE INSTRUMENT WAS FORCED BACK BY HAND. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CLARIFIED THAT THE DEFECTIVE INSTRUMENT INVOLVED WITH THE COMPLAINT WAS THE CADIERE FORCEPS INSTRUMENT. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY THAT WAS NOTED PRIOR TO USE. THE SURGICAL PORT INCISION WAS NOT INCREASED IN ORDER TO REMOVE THE CADIERE FORCEPS INSTRUMENTS AND THE CANNULA TOGETHER. THERE WAS NO INSTRUMENT OR TOOL COLLISION. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645870 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-08 K11211025 0473 00886874119778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES